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Good Manufacturing Practice (GMP)

21 CFR Part 110

GMP contains ten principles that introduces employees to critical behaviors established by FDA and industry leaders to maintain good manufacturing practices in plants.

Ten GMP Principles

1. Writing procedures
2. Following written procedures
3. Documenting for traceability
4. Designing facilities and equipment
5. Maintaining facilities and equipment
6. Validating work
7. Job competence
8. Cleanliness
9. Component control
10. Auditing for compliance

Overview of GMP Practices for Food

Personnel

—Any person who is shown to have an illness or any abnormal source of microbial contamination that may cause food contamination shall report such conditions and be excluded from operations.

—All persons working with food processing shall conform to hygienic practices such as wearing outer garments, washing/sanitizing hands, maintaining gloves, and wearing hair nets.

Plant & Grounds

—The grounds about a food plant under the control of the operator shall protect against food contamination. Methods include properly storing equipment, removing litter and waste, etc.

—Plant building and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations. Buildings shall be in good repair, provide adequate lighting, etc.

Sanitary Operations

—Building, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair to prevent food from becoming adulterated within the meaning of the act.

—Cleaning and sanitizing substances shall be free from undesirable microorganisms and shall be safe under the conditions of use. Toxic chemicals shall be identified and stored properly.

—No pests shall be allowed in any area of a food plant. Effective measures shall be taken to exclude pests from the processing areas and to protect against pest contamination.

—All food-contact surfaces shall be cleaned as frequently as necessary to protect against contamination.

—Cleaned and sanitized portable equipment and utensils should be stored in a location and manner that protects against contamination.

Sanitary Facilities & Controls

—Hand washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature.

—Rubbish and offal shall be so conveyed, stored, and disposed of as to minimize the development of odor and protect against pests and food contamination.

Equipment & Utensils

—All plant equipment and utensils shall be adequately cleanable and properly maintained.

—Instruments and controls used for regulating or recording temperatures, pH, or other conditions shall be adequately maintained, and adequate in number for their designated uses.

Processes & Controls

—Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption.

—Overall sanitation of the plant shall be under the supervision of one or more competent individuals.

—Use of a quality control operation in which the CCPs are identified and controlled during manufacturing.

 

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